---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-021801"
form_type: "8-K"
ticker: "RYTM"
cik: "0001649904"
company_name: "RHYTHM PHARMACEUTICALS, INC."
filed_at: "2026-03-02T23:59:59+00:00"
generated_at: "2026-05-15T22:40:36.804057+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Rhythm reports additional positive Phase 3 TRANSCEND data for setmelanotide in hypothalamic obesity

## Summary
- Placebo-adjusted BMI reduction of 18.8% (N=142); primary endpoint met with -16.4% BMI change on setmelanotide vs +2.4% on placebo (p<0.0001).
- In patients aged 12+ (n=98), setmelanotide group showed 2.5-point reduction in weekly average most hunger score vs 1.3-point for placebo (p=0.0015).
- sNDA under FDA review with PDUFA goal date of March 20, 2026; company submits final data package on March 2, 2026.
- EMA reviewing Type II variation; CHMP opinion expected Q2 2026, potential EU marketing auth in H2 2026.

## SEC filing metadata
- accession: 0001104659-26-021801
- form_type: 8-K
- ticker: RYTM
- cik: 0001649904
- company_name: RHYTHM PHARMACEUTICALS, INC.
- filed_at: 2026-03-02T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649904/000110465926021801/0001104659-26-021801-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649904/000110465926021801/tm267699d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-021801
- JSON: https://secwatch.observer/filing/0001104659-26-021801.json
- Plain text: https://secwatch.observer/filing/0001104659-26-021801.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.